Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 202-794-6 | CAS number: 99-85-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- p-mentha-1,4-diene
- EC Number:
- 202-794-6
- EC Name:
- p-mentha-1,4-diene
- Cas Number:
- 99-85-4
- Molecular formula:
- C10H16
- IUPAC Name:
- p-mentha-1,4-diene
Constituent 1
- Specific details on test material used for the study:
- The following information concerning identity and composition of the test item was provid-ed by the sponsor.
Name Gamma Terpinene
Batch no. 161215
Appearance Clear liquid
Composition p-mentha-1,4-diene
Purity 98%
Homogeneity homogeneous
Expiry date 14.Dec. 2018
Storage Room Temperature (20 ± 5 °C), keep away from light
The following additional information was relevant to the conduct of the study, according to
OECD 439:
CAS No. 99-85-4
EINECS-No. 202-794-6
Stability H2O: unknown; EtOH: unknown; acetone: unknown; CH3CN: unknown; DMSO: unknown
Solubility H2O: < 0.1 g/L; EtOH: unknown; acetone: unknown; CH3CN: unknown; DMSO: unknown
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: human-derived epidermal keratinocytes which have been cultured to form a multi-layered, highly differentiated model of the human epidermis.
- Cell source:
- other: commercially available EpiDermTM-Kit, procured by MatTek.
- Source strain:
- other: human
- Details on test system:
- Specification
The test system is a commercially available EpiDermTM-Kit, procured by MatTek.
The EpiDermTM tissue consists of human-derived epidermal keratinocytes which have been cultured to form a multi-layered, highly differentiated model of the human epidermis. It consists of organized basal, spinous and granular layers, and a multi-layered stratum corneum containing intercellular lamellar lipid layers representing main
lipid classes analogous to those found in vivo. The EpiDermTM tissues are cultured on specially prepared cell culture inserts.
Origin
EpiDermTM tissues were procured from MatTek In Vitro Life Science Laboratories, Brati-slava.
Designation of the kit: EPI-212-SIT
Day of delivery: 25. Apr. 2017
Batch no.: 25809 - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Duration of treatment / exposure:
- 60 minutes
- Duration of post-treatment incubation (if applicable):
- 42 hours and 30 minutes
- Number of replicates:
- 6
Test system
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- tissue 1-Positive Control
- Value:
- 4.1
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- tissue 2-Positive Control
- Value:
- 3.6
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- tissue 3-Positive Control
- Value:
- 3.9
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- tissue 1-test item
- Value:
- 100.3
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- tissue 2-test item
- Value:
- 95.4
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- tissue 3-test item
- Value:
- 104.6
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- other: The test item is considered as non-irritant to skin.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
